A clinical stage Biopharmaceutical company who are developing pioneering T Cell therapies for the treatment of cancer are seeking a Principal QC Scientist to join their expanding GMP operations based in Stevenage. They are manufacturing therapies for use in Phase I and II clinical trials with these progressing to their respective latter stages soon. Thus, the need to recruit addition expertise into the team for an SME in QC test methods and support clinical trial manufacturing.
As a Principal QC Scientist, you will be an SME in the Quality Control department to support the delivery of high quality T – Cell products for trials. This is an expanding operation meaning you will have the chance to contribute to the strategy and develop your career in the longer term as part of a high performing team. As well as use your expertise to develop, optimise and implement new methods. Please note this role works on a Monday to Friday shift pattern of early and late day shifts with an additional allowance on top of base salary.
- Operate as an SME for cross functional projects and for QC test methods and techniques
- Support clinical trial manufacturing by conducting QC testing
- Lead he transfer of methods from Process Development to Quality Control.
- Lead qualification and validation activities
- Design and execute stability programmes
- Lead investigations for OOS / QERs / Change Controls
- Manage GMP and SOP compliance
- Contribute to the development of the team – line management opportunities and training of junior staff.
Desired Skills and Experience:
- Proven experience within Biotech / Biopharmaceutical / Biologics or related Industry experience
- GMP QC Experience
- Degree or higher degree in relevant life science
- Experience of biopharmaceutical and cell based techniques e.g. flow cytometry, mammalian cell culture, potency testing, aseptic techniques, qPCR
- Understanding of Cell Biology and Immunology
The Company: The company are a pioneering and ambitious Biopharmaceutical company who have developed next-generation, programmed T-cell therapies to treat haematological cancers and solid tumours. Scientifically, the company has extremely exciting technologies, using a broad suite of proprietary and modular T-cell programming to engineer precisely targeted, controlled and highly active T cells. Commercially, they have a pipeline of product candidates in development (for the treatment of haematological malignancies and solid tumours) and is increasing its GMP production capacity. Based in a state-of-the-art facility in Stevenage, Hertfordshire, you will join a team that is doing something genuinely meaningful.